RD274 - Report to the Commissioner: Activities of the Virginia Department of Health Institutional Review Board for Calendar Year 2008


Executive Summary:
The Virginia’s State Board of Health’s regulations for the conduct of human research became effective on July 1, 1993. According to those regulations, prior to the initiation of a human research project by any institution or agency funded or licensed by the health department, a description of the proposed human research project must be submitted to a research review committee for review and approval. The Virginia Department of Health (VDH) had been relying on the research review committees of academic institutions around the state. However, this precluded VDH’s ability to conduct research that did not have a co-investigator at an academic institution. A committee was formed in the spring of 2000 to explore the viability of developing a research review committee (Institutional Review Board) at VDH and a determination was made to proceed. Committee members were appointed and a policy document, The Institutional Review Board (IRB) of the Virginia Department of Health (VDH): Guidelines and Procedures for Obtaining Review, was developed and approved by the Commissioner in January 2001 and updated in March 2005.

The Office for Human Research Protections (OHRP), within the U.S. Department of Health and Human Services, is responsible for ensuring the safety and welfare of people who participate in HHS-sponsored research. VDH has voluntarily registered and has applied for and received Federalwide Assurance for its IRB from OHRP. Registration with OHRP facilitates DHHS’s effort to establish effective communication with IRBs. In addition, receiving an assurance from OHRP makes formal an institution’s commitment to protect human subjects.